College voor de toelating van gewasbeschermingsmiddelen en biociden

Introduction

The EU renewal program concerns the renewal of active substance and the re-evaluation of plant protection products based on these substances.

The Ctgb will inform applicants online about the requirements and major updates.

Index Ctgb content on renewals of plant protection products (art. 43)

  1. Background
  2. Ctgb procedures for current authorization in relation to PPP renewal submission
  3. Ctgb presubmission procedures for PPP renewal applications
  4. Submission of application to Ctgb
  5. Ctgb evaluation
  6. Abbreviations and links

1 Background & introduction

A short introduction on Ctgb guidelines for Renewal of Plant Protection Products (Article 43 of Regulation 1107/2009) AIR 2 and higher groups:

1.1 Active substance renewals
1.2 Plant Protection Products renewals
1.3 EU guidance on PPP renewals
1.4 Ctgb aim

3. Ctgb presubmission procedures for PPP renewal applications

Index chapter 3 Ctgb presubmission procedures for PPP renewal applications

3.1 Assignment of Ctgb as ZRMS or as CMS
3.2 Pre-notification deadline
3.3 Full notification deadline
3.4 Presubmission questions and meetings
3.5 Extension of submission deadline for the dRR

5 Ctgb evaluation

Index chapter 5 Ctgb evaluation

5.1 Time lines
5.2 Data matching check
5.3 Supplementary data submission
5.4 Comparative assessment
5.5 Data protection

2 Procedures for current authorization

Index chapter 2 Ctgb procedures for current authorization:

2.1 Renewal for each active substance
2.2 Duration of authorizations
2.3 Expiration of the authorization in case no application for renewal was or can be submitted
2.4 Administrative extension of the current authorization of PPPs


4. Submission of application to Ctgb

Index chapter 4. Submission of application to Ctgb:

4.1 Submission deadline and requirements
4.2 Dossier requirements
4.3 Specific points of attention for aspects
4.4 Confirmatory data
4.5 Amendments are not accepted (with a few exceptions)
4.6 Minor uses
4.7 Fees










Abbreviations and links

• PPP: Plant Protection Product
AS
: Active substance (Where Active Substance is written in the webpages about renewals, this is also considered to apply to Safeners and Synergists)
DoA
: Date of Application as stated in the renewal regulation of the AS.
1107/2009: EC Regulation 1107/2009
Ctgb SD: Ctgb Service Desk
(I)ZRMS: (Inter)Zonal Rapporteur Members State
CMS
: Concerned Member States
EC: European Commission
PPP-URD: Ultimate Renewal Date for plant protection products = 1 year after the DoA as stated in the renewal regulation for the active substance (section 3.4 of EU GD art 43)
IZSC:interzonal steering committee
CZSC: central zone steering committe

Links

EU GD art 43: EU Guidance Document on art 43 PPP renewals (SANCO/2010/13170 rev. 13, 14 July 2015)
EU Pesticide database
Ctgb account manager